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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K210185
Device Name CardioCurve Steerable Sheath
Applicant
Talon Surgical
6030 W Harold Gatty Dr.
Salt Lake City,  UT  84116
Applicant Contact Jay Muse
Correspondent
Talon Surgical
6030 W Harold Gatty Dr.
Salt Lake City,  UT  84116
Correspondent Contact Jay Muse
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/25/2021
Decision Date 07/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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